DK171747B1 - dilatation catheter - Google Patents

dilatation catheter Download PDF

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Publication number
DK171747B1
DK171747B1 DK023293A DK23293A DK171747B1 DK 171747 B1 DK171747 B1 DK 171747B1 DK 023293 A DK023293 A DK 023293A DK 23293 A DK23293 A DK 23293A DK 171747 B1 DK171747 B1 DK 171747B1
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DK
Denmark
Prior art keywords
balloon
dilatation catheter
mesh
section
metal
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DK023293A
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Danish (da)
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DK23293A (en
DK23293D0 (en
Inventor
Gianni Leoni
Original Assignee
Metra Aps
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Priority to DK023293A priority Critical patent/DK171747B1/en
Publication of DK23293D0 publication Critical patent/DK23293D0/en
Priority to DE69424862T priority patent/DE69424862T2/en
Priority to AU62023/94A priority patent/AU6202394A/en
Priority to US08/513,908 priority patent/US5772681A/en
Priority to AT94908984T priority patent/ATE193657T1/en
Priority to EP94908984A priority patent/EP0687189B1/en
Priority to PCT/DK1994/000086 priority patent/WO1994020166A1/en
Publication of DK23293A publication Critical patent/DK23293A/en
Application granted granted Critical
Publication of DK171747B1 publication Critical patent/DK171747B1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/104—Balloon catheters used for angioplasty
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1084—Balloon catheters with special features or adapted for special applications having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands

Abstract

PCT No. PCT/DK94/00086 Sec. 371 Date Oct. 30, 1995 Sec. 102(e) Date Oct. 30, 1995 PCT Filed Mar. 2, 1994 PCT Pub. No. WO94/20166 PCT Pub. Date Sep. 15, 1994A dilation catheter comprising a sealed distal end section (8), an open proximal end section (3) and an elongated middle section with an elongated flexible balloon section (11). The middle section comprises an inner elastic tube (1), a reinforcement net (2) made of metallic monofilaments surrounding the inner tube (1) and an outer elastic tube (6) surrounding the reinforcement net (2). The reinforcement net (2) is made of metallic monofilaments crossing each other and being helically wound around the longitudinal axis of the middle section. There is no special bond between the monofilaments so that said filaments are moveable with respect to each other in the crossover points (5) during expansion of the balloon section (11). As a result the entire catheter assumes the geometrical configuration of the blood vessel during insertion and inflation of the dilation section without noticeable axial dislocation or distortion of the natural bent of the blood vessel.

Description

DK 171747 B1DK 171747 B1

Opfindelsen angår et dilatationskateter omfattende en lukket, distal endedel, en åben, proksimal endedel og en aflang mellemdel, hvori et afsnit udgøres af en aflang, fleksibel ballondel, som ved tilførsel af trykfluidum gennem den proksimale 5 endedel kan bringes til at ekspandere og indtage en form med i hovedsagen konstant tværsnit, hvilken mellemdel består af en indre, elastisk slange, et forstærkningsnet af metalmonofilament, der omslutter den indre slange, og en ydre, elastisk slange, der omslutter forstærkningsnettet, og hvilken mellem-10 del uden for ballondelen er i hovedsagen uekspanderbar eller ekspanderbar i mindre grad end ballondelen.The invention relates to a dilatation catheter comprising a closed distal end portion, an open proximal end portion, and an elongate intermediate portion, wherein a portion is an elongated, flexible balloon portion which, upon application of pressure fluid through the proximal end portion, can be expanded and consumed. a substantially constant cross-sectional shape, said intermediate portion consisting of an inner elastic tube, a metal monofilament reinforcement mesh enclosing the inner tube, and an outer elastic tube enclosing the reinforcement mesh, and the intermediate portion outside the balloon portion being in substantially expandable or expandable to a lesser extent than the balloon portion.

Det har altid være ønskeligt for læger inden for radiologi, kardiologi og urologi at kunne foretage dilatationsindgreb med systemer, som i oppustet tilstand tillader krumme konfigura-15 tioner. Allerede i midten af I960'erne var de to kendte læger, Judkins og Dottier, de første til at introducere et system for dilatation af blodkar, idet de anvendte et koaksialt dobbelt-kateter-system. Denne ældre teknik blev senere yderligere udviklet af en meget kendt læge, som gav navn til det berømte 20 Gruentzig-ballonkateter, der har fundet anvendelse inden for coronarangioplastik, mere kendt som "PTCA" (percutaneous transluminal coronary angioplasty). De forskellige konstruktioner af ballondilatationskatetere kan i hovedtræk inddeles i to hovedgrupper. I den ene hovedgruppe er ballonen normalt 25 ikke forstærket, dvs. ikke laminatformet, og ballonen er limet fast på et yderskaft med to lumen, hvor den ene lumen tjener til ballonoppustning, og den anden til en guide-wire. Den anden hovedgruppe består af koaksiale konstruktioner, dvs. arbejder efter et teleskopisk princip, hvor fluidum vandrer 30 mellem to lag, som er i direkte forbindelse med ballonen i den distale ende.It has always been desirable for physicians in radiology, cardiology and urology to be able to perform dilatation procedures with systems that allow inflated configurations in inflated condition. Already in the mid-I960s, the two known physicians, Judkins and Dottier, were the first to introduce a blood vessel dilatation system, using a coaxial dual-catheter system. This older technique was later further developed by a very well known physician who named the famous 20 Gruentzig balloon catheter which has been used in coronary angioplasty, more commonly known as "percutaneous transluminal coronary angioplasty" (PTCA). The various balloon dilation catheter designs can be broadly divided into two main groups. In one main group, the balloon is usually not reinforced, ie. not laminate-shaped, and the balloon is glued to a two-lumen outer shaft, one lumen serving for balloon inflating and the other to a guide wire. The second main group consists of coaxial structures, viz. operates on a telescopic principle where fluid travels between two layers which are in direct contact with the balloon at the distal end.

I den første hovedgruppe er det mest kendte patentskrift inden for ballondilatationskatetre US-patentskrift-4.195.637. Dette patentskrift beskriver, at ballonen antager en lige cylindrisk 35 konfiguration, når den er ekspanderet under trykpåvirkning.In the first major group, the most well-known patent in the field of balloon dilatation catheters is US Patent 4,195,637. This patent discloses that the balloon assumes a straight cylindrical configuration when expanded under pressure.

DK 171747 B1 2DK 171747 B1 2

Dette mest kendte og måske mest anvendte system for dilatation af blodkar har ikke indbygget større bøjelighedsmuligheder.This most well-known and perhaps most widely used system for dilating blood vessels has not built in greater flexibility.

En anden mindre anvendt teknik til dilatation er som tidligere nævnt det koaksiale system, som har den ulempe, at det under 5 ballonens oppustning medfører en forskydning af selve kateteret i forhold til blodkar. Yderligere dannes også her en lige cylindrisk ubøjelig ballon, jf. US-patentskrift-4.706.607 og DK-B-154870. En anden variation af forstærket laminatkonstruktion til balloner er angivet i GB-patentskrift-1.566.674. Den-10 ne konstruktion af ballondilatationskateter, som arbejder efter det teleskopiske princip, bygger på et kompensationselement under ballonens sammentrækning, når den er udsat for indvendigt tryk. Ligeledes er denne konstruktion ikke egnet til bøjelighed eller krumning under ballonoppustning.Another less-used technique for dilatation is, as mentioned earlier, the coaxial system, which has the disadvantage that during inflation the balloon causes a displacement of the catheter itself relative to blood vessels. In addition, a straight cylindrical rigid balloon is also formed here, cf. US Patent 4,706,607 and DK-B-154870. Another variation of reinforced laminate balloon construction is disclosed in GB Patent 1,566,674. This balloon dilation catheter construction, which operates on the telescopic principle, is based on a compensation element during balloon contraction when subjected to internal pressure. Also, this structure is not suitable for flexing or curvature during balloon inflating.

15 En tredje konstruktion af ballondilatationskatetere, specielt anvendt inden for PTCA, er kendt fra EP-A1-0.388.486. Dette kendte ballondilationskateter tillader forskellige indstillinger af ballondiameteren i forhold til de tidligere nævnte, idet der i den proximale ende findes en regulator, som til-20 lader en aksial ændring af masken i balIon-sektionen. I det nævnte offentliggørelsesskrift, hvor der til ballondilatationskateteret også anvendes metalfilament som forstærkningsmedie, er ikke nærmere omtalt de muligheder, der findes for frit bevægelige berøringspunkter i maskerne i et netværk i en la-25 minatkonstruktion under svag ydre kraftpåvirkning. Ligeledes er denne konstruktion ikke egnet til bøjelighed eller krumning under ballonoppustning.A third construction of balloon dilatation catheters, especially used in PTCA, is known from EP-A1-0,388,486. This prior art balloon dilation catheter permits various balloon diameter adjustments to those previously mentioned, with a proximal end providing a regulator which permits an axial change of the mask in the balloon section. In the aforementioned publication, in which the balloon dilatation catheter also uses metal filament as the reinforcing medium, the possibilities available for freely moving contact points in the masks of a network in a laminate structure under weak external force are not mentioned. Also, this structure is not suitable for flexing or curvature during balloon inflating.

Formålet med opfindelsen er at tilvejebringe et dilatationskateter med en bøjelig ballondel, som antager blodbanens rumlige 30 geometriske konfiguration, og som tillader en dilatation af indsnævrede blodkar eller organer uden distortioner og dislokationer af disse under ballondelens oppustning.The object of the invention is to provide a dilatation catheter with a flexible balloon portion which assumes the spatial geometric configuration of the bloodstream and permits dilatation of constricted blood vessels or organs without distortions and dislocations thereof during inflating of the balloon portion.

Dilatationskateteret er ifølge opfindelsen ejendommeligt ved, DK 171747 Bl 3 at forstærkningsnettet er udført af krydsende metalmonofila-menter, der er anbragt skruespiralformet om mellemdelens længdeakse med skruespiralerne anbragt inden i hinanden eller sammenflettet, at forstærkningsnettet i det mindste i ballon-5 delen i dennes ekspanderede tilstand er i anlæg mod den indre slanges yderflade og den ydre slanges inderflade, og at der ingen særlige bindinger findes mellem monofilamenterne, hvorved disse under ballondelens ekspansion kan bevæge sig i forhold til hinanden i krydsningspunkterne.According to the invention, the dilatation catheter is characterized in that the reinforcing mesh is made of intersecting metal monofilaments arranged helically about the longitudinal axis of the intermediate part with the helical coils disposed within or interlaced, at least in the balloon portion of the reinforcing mesh 5. condition is in contact with the outer surface of the inner tube and the inner surface of the outer tube, and that no special bonds exist between the monofilaments, whereby during the expansion of the balloon part they can move relative to each other at the points of intersection.

10 Alternativt er dilatationskateteret ifølge opfindelsen ejendommeligt ved, at forstærkningsnettet er et strikket netværk af metalmonofilament, hvor netværkets maskerækker forløber skruespiralformet om mellemdelens længdeakse, at forstærkningsnettet i det mindste i ballondelen i dennes ekspanderede 15 tilstand er i anlæg mod den indre slanges yderflade og den ydre slanges inderflade, og at der ingen særlige bindinger findes mellem de afsnit af monofilamentet, som indgår i maskerne, hvorved disse afsnit under ballondelens ekspansion kan bevæge sig i forhold til hinanden i krydsningspunkterne.Alternatively, the dilatation catheter of the invention is characterized in that the reinforcing mesh is a knitted metal monofilament network in which the mesh meshes of the mesh extend helically about the longitudinal axis of the intermediate portion, that the reinforcing mesh is at least in the balloon portion in its expanded state, abutting the outer surface and the inner tube. the inner surface of the tubing, and that no special bonds exist between the sections of the monofilament contained in the masks, whereby these sections during the balloon section expansion can move relative to each other at the intersection points.

20 Anvendelse af en sådan opbygget laminat-konstruktion ifølge opfindelsen - bestående af et lag indre slange, et forstærkningsnet og et lag ydre slange - til et dilatationskateter har den fordel i forhold til andre laminatkonstruktioner til samme formål, hvor den forstærkende del med almindelige plastfila-25 menter (nylon, polyester etc.) danner et lige, cylinderformet emne under indvendig trykpåvirkning af en væske, at den tillader en blivende bøjning af selve forstærkningsnettet uden blivende deformationer i det filamentformede metal. Det af metalmonofilament ved skruespiraldannelse, fletning eller 30 strikning fremstillede forstærkningsnet, som netop er den forstærkende del i laminat-konstruktionen til at modstå indvendigt tryk, kan ved meget svage ydre påvirkninger antage forskellige og blivende konfigurationer i rummet på grund af, at forstærkningsnettets berøringspunkter er frit drejelige, og 35 herved afviger laminat-konstruktionen fra den kendte lige, cy- DK 171747 Bl 4 linderformede ballonkonstruktion. Nærværende opfindelse omfatter alle mulige geometriske, rumlige konfigurationer. Sådanne konfigurationer i rummet dannes ved, at den krummede arterie eller vene medvirker til at indpasse hele kateteret i ikke-5 oppustet tilstand, og derefter vil den ekspanderbare del (ballondel) gennem indre trykpåvirkning antage en endelig yderdiameter med den naturlige bøjningsgrad, som arteriekonfigurationen har.Use of such a built-up laminate structure according to the invention - consisting of a layer of inner tube, a reinforcing net and a layer of outer tube - for a dilation catheter has the advantage over other laminate structures for the same purpose, wherein the reinforcing member with ordinary plastic filaments. Twenty-five (nylon, polyester, etc.) form a straight, cylindrical workpiece, under the internal pressure of a liquid, to allow a continuous bending of the reinforcing mesh itself without permanent deformation in the filamentous metal. The reinforcing mesh made of metal monofilament by helix, braid or knitting, which is precisely the reinforcing part of the laminate structure to withstand internal pressure, can assume very different and lasting configurations in the room due to the contact points of the reinforcing mesh being very weak. freely rotatable, and thus the laminate structure differs from the known straight, cylindrical balloon structure. The present invention encompasses all possible geometric spatial configurations. Such configurations in space are formed by the curved artery or vein helping to fit the entire catheter in the non-inflated state, and then the expandable portion (balloon portion) through internal pressure will assume a final outer diameter with the natural degree of flexion of the arterial configuration. .

I princippet kan en sådan konstruktion anvendes til forskelli-10 ge formål, idet det primære formål er at skabe en tilpasning til omgivelserne. Opfindelsen muliggør, at dilatation af et forsnævret blodkar eller andet inficeret kropselement kan foretages uden aksiale distortioner eller rumlige dislokationer, som det er tilfældet med de eksisterende ballonkatetere, for-15 stærkede eller ikke forstærkede.In principle, such a construction can be used for a variety of purposes, the primary purpose being to adapt to the environment. The invention enables dilatation of a constricted blood vessel or other infected body element to be performed without axial distortions or spatial dislocations, as is the case with the existing balloon catheters, enhanced or uninhibited.

Ifølge en første udførelsesform for opfindelsen kan metalmono-filamentet have en maksimal brudforlængelse på 5%.According to a first embodiment of the invention, the metal mono filament can have a maximum fracture elongation of 5%.

Den indre og den ydre elastiske slange kan ifølge en anden udførelsesform for opfindelsen hensigtsmæssigt være udført af 20 termoplast.According to another embodiment of the invention, the inner and outer elastic tubing may conveniently be made of thermoplastic.

Dilatationskateteret kan ifølge en tredje udførelsesform for opfindelsen være således udformet, at der i mellemdelen indgår et uekspanderbart afsnit af større længde end ballondelen.According to a third embodiment of the invention, the dilatation catheter may be so designed as to include in the intermediate portion an expandable portion of greater length than the balloon portion.

Endvidere kan dilatationskateteret ifølge en fjerde udførel-25 sesform for opfindelsen være indrettet til at optage en guide-wire i dets indre lumen.Furthermore, according to a fourth embodiment of the invention, the dilatation catheter may be arranged to receive a guide wire in its inner lumen.

Opfindelsen forklares nærmere nedenfor under henvisning til tegningen, hvor fig. 1 viser et længdesnit gennem et kendt dilatationskateter 30 med en ballondel indført i et blodkar, DK 171747 B1 5 fig. 2 et længdesnit gennem en udførelsesform for et dilatationskateter ifølge opfindelsen indført i det samme blodkar som i fig. 1, fig. 3 i større målestok et længdesnit gennem dilatationskate-5 teret i fig. 2 i bøjet stilling, og fig. 4 skematisk et tværsnit gennem en opstilling til måling af bøjelighedsgrad.The invention is explained in more detail below with reference to the drawing, in which fig. 1 is a longitudinal section through a known dilatation catheter 30 with a balloon portion inserted into a blood vessel; FIG. 2 is a longitudinal section through an embodiment of a dilatation catheter according to the invention inserted into the same blood vessel as in FIG. 1, FIG. 3 is a longitudinal section through the dilatation catheter of FIG. 2 in a bent position, and FIG. 4 is a schematic cross-section through an arrangement for measuring the degree of flexibility.

Fig. 1 viser et kendt dilatationskateter med en ballondel 12, som er indført i en patients blodkar 13 med stenose 14. Bal-10 londelen 12 befinder sig i oppustet tilstand under dilatationsindgreb på patienten og udviser en lige, cylindrisk konfiguration. Den med en pil angivne distortionsretning og med en anden pil viste dislokationsretning viser, at der er fare for beskadigelse af patientens blodkar.FIG. Figure 1 shows a known dilatation catheter having a balloon portion 12 inserted into a patient's blood vessel 13 with stenosis 14. The balloon 10 portion 12 is in inflated condition during dilatation engagement on the patient and exhibits a straight, cylindrical configuration. The direction of distortion indicated by an arrow and the direction of dislocation indicated by another arrow indicates that there is a risk of damage to the patient's blood vessels.

15 Fig. 2 og 3 angår et dilatationskateter ifølge opfindelsen.FIG. 2 and 3 relate to a dilatation catheter according to the invention.

Det i fig. 3 viste dilatationskateter har en bøjelig ballondel 11, som består af en indre elastisk slange 1 af polymer, der danner et kammer for fluidum. I anlæg mod denne slanges ydre overflade er der anbragt et forstærkningsnet 2 af metalmonofi-20 lament, hvilket forstærkningsnets maskerækker forløber skruespiralformet om ballondelens 11 længdeakse med en afvigelse fra neutral vinkel (54,7°). Maskerækkernes berøringspunkter uden/under indvendigt tryk, dvs. under ballondelens ekspansion, kan bevæge sig i forhold til hinanden i krydsningspunkter-25 ne 5. I fortsættelse af ballondelens 11 maskerækker er der anbragt en længere sektion {endedel) 3 af maskerækker i en neutral vinkel, idet et kort overgangsstykke 4 danner et sammenhængende netværk mellem kateterskaft 3 og ballondel 11. I den distale endedel 8 er der ligeledes et sammenhængende kort 30 overgangsstykke fra ballondelens maskevidde i en ikke-neutral vinkel til en sektion {endedelen 8) af maskerækker i neutral vinkel. Uden på forstærkningsnettet 2 er der en ydre, elastisk DK 171747 B1 6 slange 6 af polymer, som udgør den ydre del af ballondelen 11.The FIG. 3 has a flexible balloon portion 11 which consists of an inner elastic tube 1 of polymer forming a chamber for fluid. In abutment to the outer surface of this hose, a reinforcement mesh 2 of metal monofilament is provided, the mesh rows of the reinforcement mesh extending helically about the longitudinal axis of the balloon portion 11 with a deviation from neutral angle (54.7 °). Mask rows touch points without / under internal pressure, ie during the expansion of the balloon part, can move relative to each other at crossing points 5. In continuation of the mesh rows of the balloon part 11, a longer section {end part) 3 of mask rows is disposed at a neutral angle, a short transition piece 4 forming a continuous network. between the catheter shaft 3 and the balloon portion 11. In the distal end portion 8, there is also a continuous short 30 transition piece from the mesh portion of the balloon at a non-neutral angle to a section {end portion 8) of mask rows at a neutral angle. Outside of the reinforcing mesh 2, there is an outer, elastic polymeric hose 6 which constitutes the outer portion of the balloon portion 11.

I den proksimale ende 7 af ballondelen 11 er der en åbning for passage af fluidum. I ballondelens 11 indre rum er der placeret et rør 9, som begynder ved dilatationskateterets konnektor 5 (ikke vist) og er fastgjort i den distale ende 8.At the proximal end 7 of the balloon portion 11 there is an opening for passage of fluid. In the inner space of the balloon portion 11 is located a tube 9, which begins at the dilatation catheter connector 5 (not shown) and is secured at the distal end 8.

Til fremstilling af et bøjeligt dilatationskateter ifølge opfindelsen er det hensigtsmæssigt at anvende en cylinderformet mandril af metal eller plast, idet man ekstruderer eller belægger via en coating et tyndt elastisk underlag 1 til dan-10 nelse af den indre slange med en tykkelse på 5/100 - 10/100 mm. Herefter forstærkes underlaget 1 med metalmonofilament med en diameter på 0,02 - 0,04 mm enten via skruespiraldannelse, især hvor denne er kombineret med fletning, eller strikning til dannelse af et forstærkningsnet 2. Derefter belægges for-15 stærkningsnettet 2 med et ydre elastisk lag 6 til dannelse af den ydre slange (plast eller gummi) med en vægtykkelse, der varierer fra 5/100 - 10/100 mm. I nærværende opfindelse er anvendt termoplastiske polyurethaner både ind- og udvendigt, dog er vulkaniseret gummi også en mulighed. Under belægning af det 20 elastiske ydre lag tilsigter man at undgå, at der dannes en kemisk eller mekanisk binding mellem berøringspunkter 5 i forstærkningsnettet 2. Det som anses for at være lettest at anvende til fremstilling af en sådan laminat-konstruktion er uden tvivl en termoplast, som foretrækkes i forhold til vulka-25 niseret gummi. Selve laminat-konstruktionen for ballon og skaft, der danner dilatationskateteret, er inddelt i tre vel-definerede sektioner. Ved hver ende 3 og 8 af det ekspanderbare emne, dvs. ballondelen 11, er forstærkningsnettet tættere armeret, dvs. antal monofilamenter pr. længdeenhed er større 30 end ved selve den ekspanderbare dels begyndelse 4, hvor vinkelafvigelsen fra neutral vinkel (54,7°) er et mindre gradtal. Neutral vinkel på 54,7° opnås under indvendig trykpåvirkning, medens ballonens to korte overgangsstykker danner ballonens skuldre. Ved sammenligning mellem en skruespiraldannet lami-35 natkonstruktion og en flettet laminat-konstruktion er den flettede konstruktion mere stabil og graden af bøjelighed større under samme ydre kraftpåvirkning.For the manufacture of a flexible dilatation catheter according to the invention, it is convenient to use a cylindrical mandril made of metal or plastic, by extruding or coating via a coating a thin elastic substrate 1 to form the inner tube 5/100 thick. - 10/100 mm. Subsequently, the substrate 1 is reinforced with metal monofilament having a diameter of 0.02 - 0.04 mm either via helical coiling, especially where it is combined with braid, or knitting to form a reinforcing mesh 2. Then the reinforcing mesh 2 is coated with an outer elastic layer 6 to form the outer tube (plastic or rubber) having a wall thickness varying from 5/100 to 10/100 mm. In the present invention, thermoplastic polyurethanes are used both internally and externally, however, vulcanized rubber is also an option. While coating the 20 resilient outer layer, it is intended to avoid the formation of a chemical or mechanical bond between touch points 5 of the reinforcing mesh 2. What is considered to be the easiest to use in the manufacture of such a laminate structure is undoubtedly a thermoplastic which is preferred over vulcanized rubber. The actual balloon and shaft laminate structure forming the dilatation catheter is divided into three well-defined sections. At each end 3 and 8 of the expandable blank, i.e. balloon portion 11, the reinforcing net is more closely reinforced, i. number of monofilaments per the unit of length is greater than at the beginning 4 of the expandable part itself, where the angle deviation from neutral angle (54.7 °) is a smaller degree number. A neutral angle of 54.7 ° is obtained under internal pressure, while the two short transition pieces of the balloon form the balloon's shoulders. When compared between a helical laminate structure and a braided laminate structure, the braided structure is more stable and the degree of flexibility greater under the same external force.

7 DK 171747 Bl7 DK 171747 Pg

Fig. 4 viser en opstilling til måling af bøjelighed. Her er foretaget målinger af bøjelighedsevne på oppustede balloner med og uden forstærkning, idet ballonerne har samme diameter 5 og længde og udsættes for samme tryk og temperatur (37°C). Et kateter, hvis ballon 11 skal måles, anbringes som en "tangent" til en rustfri cylinderdorn 16 med en diameter på 18 mm. Den ene ende af ballonen 11 fastholdes, mens den anden bøjes rundt om dornen 16 til 180°. Den lodrette kraft F, der kræves for at 10 holde de 180° bøjning, måles. Her er anvendt et kalibreret fjederdynamometer. Resultaterne er vist i tabel 1.FIG. 4 shows an arrangement for measuring flexibility. Here, measurements of flexibility of inflated balloons were made with and without reinforcement, the balloons having the same diameter 5 and length and subjected to the same pressure and temperature (37 ° C). A catheter whose balloon 11 is to be measured is placed as a "tangent" to a stainless steel mandrel 16 having a diameter of 18 mm. One end of the balloon 11 is held while the other is bent around the mandrel 16 to 180 °. The vertical force F required to hold the 180 ° bend is measured. A calibrated spring dynamometer is used here. The results are shown in Table 1.

Tabel 1 TYPE BALLONDIAM. TRYK KRAFT STANDARDAFV.Table 1 TYPE BALLONDIAM. PRESS POWER STANDARD DRAW.

15 mm MPa N N15 mm MPa N N

Metalfilament- forstærket 2,70 1,2 0,12 0,03 -do- 1,30 0,0 0,07 0,01Metal Filament Reinforced 2.70 1.2 0.12 0.03 -do- 1.30 0.0 0.07 0.01

Plastfilament- 20 forstærket 2,70 1,2 1,43 0,21 -do- 1,35 0,0 0,67 0,14Plastic filament-reinforced 2.70 1.2 1.43 0.21 -do- 1.35 0.0 0.67 0.14

Uforstærket 2,70 1,2 IM IMUnstated 2.70 1.2 IM

(IM = ikke mulig)(IM = not possible)

Tallene er gennemsnittet af 6 målinger.The numbers are the average of 6 measurements.

25 _25 _

Nedenstående tabel 2 viser ændringer i gradtallene for en med metalmonofilament forstærket ballon som funktion af trykket.Table 2 below shows changes in the degree numbers of a balloon reinforced with metal monofilament as a function of pressure.

Ved trykket nul er ballondelen bøjet 90°, og trykket stiger derefter.At zero pressure, the balloon portion is bent 90 ° and the pressure then increases.

Claims (6)

1. Dilatationskateter omfattende en lukket, distal endedel DK 171747 B1 9 (8) , en åben, proksimal endedel (3) og en aflang mellemdel, hvori et afsnit udgøres af en aflang, fleksibel ballondel (11) , som ved tilførsel af trykfluidum gennem den proksimale endedel (3) kan bringes til at ekspandere og indtage en form 5 med i hovedsagen konstant tværsnit, hvilken mellemdel består af en indre, elastisk slange (1), et forstærkningsnet (2) af metalmonofilament, der omslutter den indre slange (1), og en ydre, elastisk slange (6), der omslutter forstærkningsnettet (2) , og hvilken mellemdel uden for ballondelen (11) er i ho-10 vedsagen uekspanderbar eller ekspanderbar i mindre grad end ballondelen (11) , kendetegnet ved, at forstærkningsnettet (2) er udført af krydsende metalmonofilamenter, der er anbragt skruespiralformet om mellemdelens længdeakse med skruespiralerne anbragt inden i hinanden eller sammenflet-15 tet, at forstærkningsnettet (2) i det mindste i ballondelen (11) i dennes ekspanderede tilstand er i anlæg mod den indre slanges (1) yder flade og den ydre slanges (6) inderflade, og at der ingen særlige bindinger findes mellem monofilamenterne, hvorved disse under ballondelens (11) ekspansion kan bevæge 20 sig i forhold til hinanden i krydsningspunkterne (5).A dilatation catheter comprising a closed distal end portion (8), an open, proximal end portion (3) and an elongated intermediate portion, wherein a portion is constituted by an elongated, flexible balloon portion (11) which, upon application of pressure fluid through the proximal end portion (3) can be expanded to assume a shape 5 of substantially constant cross-section, the intermediate portion consisting of an inner, elastic hose (1), a reinforcing mesh (2) of metal monofilament enclosing the inner hose (1). ), and an outer, elastic hose (6) enclosing the reinforcing net (2), and which intermediate portion outside the balloon portion (11) is substantially non-expandable or expandable to a lesser extent than the balloon portion (11), characterized in that the reinforcing net (2) is made of intersecting metal monofilaments arranged helically about the longitudinal axis of the intermediate member with the helical coils disposed within or interlaced that the reinforcing net (2) at least in the balloon portion (11) of its expanded state abuts the outer surface of the inner tube (1) and the inner surface of the outer tube (6), and that no special bonds exist between the monofilaments whereby, during the expansion of the balloon (11), they can move relative to each other at the intersection points (5). 2. Dilatationskateter omfattende en lukket, distal endedel (8) , en åben, proksimal endedel (3) og en aflang mellemdel, hvori et afsnit udgøres af en aflang, fleksibel ballondel (11) , som ved tilførsel af trykfluidum gennem den proksimale 25 endedel (3) kan bringes til at ekspandere og indtage en form med i hovedsagen konstant tværsnit, hvilken mellemdel består af en indre, elastisk slange (1), et forstærkningsnet (2) af metalmonofilament, der omslutter den indre slange (1), og en ydre, elastisk slange (6), der omslutter forstærkningsnettet 30 (2) , og hvilken mellemdel uden for ballondelen (11) er i ho vedsagen uekspanderbar eller ekspanderbar i mindre grad end ballondelen (11) , kendetegnet ved, at forstærkningsnettet (2) er et strikket netværk af metalmonofilament, hvor netværkets maskerækker forløber skruespiralformet om mel-35 lemdelens længdeakse, at forstærkningsnettet (2) i det mindste i ballondelen (11) i dennes ekspanderede tilstand er i anlæg DK 171747 B1 10 mod den indre slanges (1) yderflade og den ydre slanges (6) inderflade, og at der ingen særlige bindinger findes mellem de afsnit af monofilamentet, som indgår i maskerne, hvorved disse afsnit under ballondelens ekspansion kan bevæge sig i forhold 5 til hinanden i krydsningspunkterne (5).A dilatation catheter comprising a closed distal end portion (8), an open proximal end portion (3), and an elongated intermediate portion, wherein a portion is constituted by an elongated, flexible balloon portion (11) which, when supplying pressure fluid through the proximal end portion (3) can be expanded and taken into shape with a substantially constant cross-section, the intermediate part consisting of an inner, elastic hose (1), a reinforcing mesh (2) of metal monofilament enclosing the inner hose (1), and a outer elastic hose (6) enclosing the reinforcing net 30 (2) and said intermediate portion outside the balloon portion (11) being substantially expandable or expandable to a lesser extent than the balloon portion (11), characterized in that the reinforcing net (2) is a knitted metal monofilament network in which the mesh meshes of the network extend helical about the longitudinal axis of the intermediate part, that the reinforcing mesh (2) at least in the balloon part (11) in its expanded state is in contact with DK 171747 B1 10 toward the outer surface of the inner tube (1) and the inner surface of the outer tube (6), and that no special bonds exist between the portions of the monofilament included in the masks, whereby these portions may move relative to each other during expansion of the balloon portion 5 at the intersection points (5). 3. Dilatationskateter ifølge krav 1 eller 2, kendetegnet ved, at metalmonofilamentet har en maksimal brudforlængelse på 5%.Dilatation catheter according to claim 1 or 2, characterized in that the metal monofilament has a maximum elongation at break of 5%. 4. Dilatationskateter ifølge krav 1 eller 2, kendete g-10 net ved, at den indre (1) og den ydre elastiske slange (6) er udført af termoplast.A dilatation catheter according to claim 1 or 2, characterized in that the inner (1) and the outer elastic tube (6) are made of thermoplastic. 5. Dilatationskateter ifølge krav 1 eller 2, kendetegnet ved, at der i mellemdelen indgår et uekspanderbart afsnit af større længde end ballondelen (11).Dilatation catheter according to claim 1 or 2, characterized in that an intermediate portion of an expandable length is larger than the balloon portion (11). 5 BALLONDIA. 1,3 1,4 1,7 2,3 2,7 2,7 2,7 2,7 mm Det var ikke muligt at foretage tilsvarende målinger for et plastfilamentforstærket (nylon) ballondilatationskateter, idet 10 ballondelen ved trykket nul var en lige cylinder og ikke kunne deformeres til en konstant vinkel, men hele tiden gik tilbage til 180°. For det uforstærkede ballondilatationskateter var situationen den samme. En væsentlig faktor for nærværende opfindelse vedrørende me-15 talfilamentforstærkede laminat-konstruktioner for balloner, specielt med flettede masker, er, at når ballonen bliver påvirket af en svag ydre kraft, dvs. f.eks. når den skal rundt i en bue, vil ballonen bibeholde den krumme facon, selv når den er udsat for indvendigt tryk, dvs. den ekspanderer. En vigtig 20 fordel ved ballonen ifølge opfindelsen i forhold til armerede balloner med plastfilameter eller uarmerede balloner er, at disse udviser en lige cylindrisk konfiguration med fare for dislokationer af blodkarrene under oppustning, se fig. 1. Som materiale til metalmonofilament til forstærkningsnet kan 25 anvendes metalblandiger, såsom NiTi. Dilatationskateteret ifølge opfindelsen kan f.eks. optage et maksimalt tryk på 25 bar.5 BALLONDIA. 1.3 1.4 1.7 2.3 2.7 2.7 2.7 2.7 mm It was not possible to make similar measurements for a plastic filament-reinforced (nylon) balloon dilation catheter, the 10 balloon portion at zero pressure being a straight cylinder and could not be deformed to a constant angle, but kept going back to 180 °. For the uninhibited balloon dilatation catheter, the situation was the same. An important factor of the present invention regarding metal filament reinforced laminate designs for balloons, especially with braided mesh, is that when the balloon is affected by a weak external force, i.e. eg. when moving around an arc, the balloon will maintain its curved shape even when subjected to internal pressure, ie. it expands. An important advantage of the balloon of the invention over reinforced balloons with plastic filament or unarmored balloons is that they exhibit a straight cylindrical configuration with danger of dislocation of the blood vessels during inflation, see FIG. 1. As metal monofilament material for reinforcement mesh, metal blends such as NiTi can be used. The dilatation catheter of the invention may e.g. record a maximum pressure of 25 bar. 6. Dilatationskateter ifølge krav 1 eller 2, kendeteg net ved at optage en guide-wire (9) i dets indre lumen.Dilatation catheter according to claim 1 or 2, characterized by accommodating a guide wire (9) in its inner lumen.
DK023293A 1993-03-02 1993-03-02 dilatation catheter DK171747B1 (en)

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Application Number Priority Date Filing Date Title
DK023293A DK171747B1 (en) 1993-03-02 1993-03-02 dilatation catheter
DE69424862T DE69424862T2 (en) 1993-03-02 1994-03-02 DILATATION CATHETER
AU62023/94A AU6202394A (en) 1993-03-02 1994-03-02 Dilation catheter
US08/513,908 US5772681A (en) 1993-03-02 1994-03-02 Dilation catheter
AT94908984T ATE193657T1 (en) 1993-03-02 1994-03-02 DILATION CATHETER
EP94908984A EP0687189B1 (en) 1993-03-02 1994-03-02 Dilation catheter
PCT/DK1994/000086 WO1994020166A1 (en) 1993-03-02 1994-03-02 Dilation catheter

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DK23293 1993-03-02
DK023293A DK171747B1 (en) 1993-03-02 1993-03-02 dilatation catheter

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DK23293A DK23293A (en) 1994-09-03
DK171747B1 true DK171747B1 (en) 1997-05-05

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EP (1) EP0687189B1 (en)
AT (1) ATE193657T1 (en)
AU (1) AU6202394A (en)
DE (1) DE69424862T2 (en)
DK (1) DK171747B1 (en)
WO (1) WO1994020166A1 (en)

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DK23293A (en) 1994-09-03
EP0687189B1 (en) 2000-06-07
DK23293D0 (en) 1993-03-02
DE69424862T2 (en) 2001-01-04
WO1994020166A1 (en) 1994-09-15
ATE193657T1 (en) 2000-06-15
US5772681A (en) 1998-06-30
AU6202394A (en) 1994-09-26
EP0687189A1 (en) 1995-12-20
DE69424862D1 (en) 2000-07-13

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